The Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People

Not Applicable

Completed

• Conditions: Acute Upper Respiratory Tract Infection

• Registration Number: NCT05879393
• Lead Sponsor: University Maribor

Brief Summary

The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Active to shorten the incidence and duration of acute upper respiratory tract infections (URTIs) in older people. The main questions it aims to answer is:

* Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the incidence of URTIs in older people?

* Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the duration of URTIs in older people?

* Is the multistrain probiotic OMNiBiOTiC® Active effective in changing selected immunological blood parameters in older people? Researchers will compare the probiotic group and the placebo group to see if the incidence or duration of URTIs are significant among the groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-07
• Primary Completion: 2022-02-13
• Study Completion: 2022-07-13
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• 65 years or older at the signing of the written consent form
• ability of participant to eat independently
• ability of participant to adhere to all procedures of the clinical study

Exclusion Criteria

• participants experienced an exacerbation of an existing chronic disease
• participants experienced an exacerbation of metabolic diseases,
• participants with mental incapacity to understand instructions
• participants were prescribed long-term usage of antibiotics.
• participants that changed their eating habits or consumed any probiotics 14 days
• participants with markedly abnormal results of blood tests were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of URTI	12 weeks supplementation	Comparison of the incidence of acute upper respiratory tract infections among older people in both arms

Secondary Outcome Measures

Name	Time	Method
Duration of URTI	12 weeks supplementation	Comparison of the duration of acute upper respiratory tract infections among older people in both arms via the use of a questionnaire
Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum	12 weeks supplementation	Differences in the serum concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils, measured in 10x9/L of the participants in the first winter season as a change from baseline to 12 weeks upon administration of probiotics compared to placebo
Changes in concentration of Immunoglobulin A (IgA) in serum	12 weeks supplementation	Differences in the serum concentration of immunoglobulin A (IgA), measured in g/L of the participants in the first winter season as a change from baseline to 12 weeks upon administration of probiotics compared to placebo

Trial Locations

Locations (1)

University of Maribor, Faculty of Health Sciences; 🇸🇮 Maribor, Slovenia